Comparison of A Single Dose Combination of Methadone and Morphine With Morphine Alone for Treating Post-operative Pain
This trial is active, not recruiting.
|Treatments||methadone, methadone and morphine|
|Sponsor||Memorial Sloan Kettering Cancer Center|
|Start date||March 2005|
|End date||March 2016|
|Trial size||70 participants|
|Trial identifier||NCT00142519, 05-025|
This is a randomized Phase II study testing the effectiveness of the combination of morphine and methadone versus morphine alone in relieving pain. A second goal is to further evaluate any side effects of the combination of morphine and methadone.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
The primary goal of this study is to compare the analgesic effects of a combination of morphine and methadone with morphine alone to determine synergistic activity of mu opioid analgesics in patients with post-operative pain.
time frame: Time to the third request for the pain medication
To determine if there are any side effects from the combination of morphine and methadone when given together.
time frame: assessed every 10 minutes
Male or female participants at least 18 years old.
Inclusion Criteria: - Retroperitoneal lymph node dissection - Planned post-operative analgesia with PCA at 1 mg continuous infusion and 1 mg every 10 minutes - 18 years of age or older - English-speaking - Give informed consent to participate in this study Exclusion Criteria: - Known hypersensitivity to methadone or morphine - Patients with past or present history of substance abuse - Patients with a history of methadone treatment - Patients with a history of chronic pain requiring daily analgesic use for more than 3 months - Patients treated with opioids within one month from the scheduled surgery - Creatinine clearance less than 50 mg/kg (using Cockcroft-Gault Equation). - Neurologic or psychiatric disease sufficient, in the doctor's opinion, to compromise data collection
|Official title||Translational Studies in Analgesic Pharmacology: Analgesic Synergy in Clinical Pain. A Phase 2 Study Comparing a Single Dose of a 1:1 Combination of Methadone and Morphine With Morphine Alone in Patients With Post-operative Pain.|
|Principal investigator||Natalia Moryl, MD|
|Description||Rationale: Experimental data demonstrates a profound analgesic synergy between morphine and methadone when co-administered systemically in mice. If this type of synergy can be demonstrated in clinical pain, it will be a relatively unique example of translating concepts of fundamental aspects of opioid actions seen in the laboratory to the clinical area, and provide a basis for offering new and scientifically- based analgesic regimens. This may provide better pain relief with less opioid related side effects in clinical practice. Purpose: This is a randomized, double blind, parallel arm Phase II study comparing a single dose of 1:1 combination of methadone and morphine with morphine alone in patients with post-operative pain. - The primary objective of this randomized, double blind, parallel arm Phase II study is to compare the analgesic effects of a combination of morphine and methadone with morphine alone to determine synergistic activity of mu opioid analgesics in patients with post-operative pain. - A second goal is to further evaluate any side effects of the combination of morphine and methadone.|
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